DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged.
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. 12/253,714, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application.
Application No. 12/253,714 fails to provide proper support for a cover that is semi-transparent. This limitation is required by independent claim 1.
As a result, the effective priority date for the instant application has been established as April 17, 2011.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-2, 4-5, 10-20 and 22-24 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Marshall (US 8,361,044) in view of Keisic (US 2011/0224636) and further in view of Salvadori et al. (US 2007/0203463).
Regarding claims 1, 2, 22 and 23, Marshall discloses urinary drainage bag assembly (Abstract, lines 1-9), comprising:
a fluid bag Y (Col. 4, lines 44-47; fig. 2) including a front panel and a rear panel sealed to each other at or near an outer edge of the fluid bag and having a fillable region and a non-fillable region;
wherein the front panel includes a volume indicator comprising graduations A (fig. 2) indicating predetermined volumes which allow a volume of urine within the fillable region to be determined by a comparison between a top of the urine and the graduations;
an inlet tube W (col. 5, line 49; fig. 2) coupled to an upper portion of the fluid bag;
an outlet tube Z (fig. 2) coupled to a lower portion of the fluid bag; and
a fluid bag cover (col. 2, lines 36-37) positioned in an obscuring orientation wherein said cover obscures at least a portion of the front panel of the fluid bag including the volume indicator set forth in col. 2, lines 36-37.
Marshall discloses that the cover includes a cutout that is a window and that the window may include a removably attached patch (59) to conceal the sleeve window when not in use for monitoring the urine bag as set forth in col. 11, lines 7-15.
Marshall does not expressly disclose that the cover is semi-transparent, i.e. urine in the fluid bag is viewable through the cover when the cover is positioned in the obscuring orientation (cl. 2) and that the bag has a hanger coupled to the upper portion of the fluid bag within the non-fillable region.
In the same field of endeavor, i.e. fluid collection bags, Keisic teaches a urine collection bag (abstract) having a semi-transparent cover as set forth in figure 1A.
It would have been obvious to one having ordinary skill in the art at the time the invention was made to supply the bag of Marshall with the transparent cover, as taught by Keisic in order to provide the patient with the ability to easily view the quantity and quality of their urine as taught by Keisic in [0028].
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Keisic includes the urine bag with straps to allow the bag to hang.
Marshall modified does not explicitly recite a hanger.
Salvadori et al. (hereinafter “Salvadori) teaches an analogous urine bag comprising a hanger (200) as shown in figure 1.
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In the same field of endeavor, i.e. fluid collection bags, Salvadori teaches a urine collection bag 10 (Abstract, line 1; fig. 1) comprising a hanger 200 (fig. 1) coupled to the upper portion of the fluid bag within the non-fillable region, and having a hook portion 204 (page 3, [0035], line 6; fig. 1), as required by claim 23, wherein a base region of the hanger is coupled within the non-fillable region (fig. 1), as required by claim 22.
It would have been obvious to one having ordinary skill in the art at the time the invention was made to supply the bag of Marshall modified with the hanger, as taught by Salvadori in order to support the bag on support structure, as motivated by Salvadori (page 3, [0035], line 3).
Regarding claim 4, see the rejection of claim 1.
Keisic teaches a cover having a translucent window.
It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the extent of the translucent window in the cover as desired since it has been held that the mere change in size and/or shape of an element previously set forth in the prior art is considered to be within the level of ordinary skill in the art.
Regarding claim 5, Marshall modified teaches the invention substantially as claimed as set forth in the rejection of claim 1.
Keisic teaches a urinary bag assembly, wherein at least a portion of the volume indicator is viewable through the cover when the cover is positioned in the obscuring orientation, since the cover is disclosed as being transparent as set forth in [0028] of Keisic.
Regarding claim 10, Marshall discloses urinary bag assembly, wherein a volume indicator defined by transparent region with graduations A (fig. 2) allowing the volume of urine in the fluid bag to be determined (col. 10, line 12).
Regarding claim 11, Marshall discloses urinary bag assembly, wherein said cover further includes a cutout 57.
Marshall discloses that the cutout is a window and that the window may include a removably attached patch (59) to conceal the sleeve window when not in use for monitoring the urine bag.
The difference between Marshall and claim 11 is the explicit recitation that the cover allows direct viewing of at least a portion of the front panel of the fluid bag without moving the cover from the obscuring orientation to a viewing orientation.
In the same field of endeavor, i.e. fluid collection bags, Keisic teaches a urine collection bag (abstract) having a semi-transparent cover as set forth in figure 1A.
It would have been obvious to one having ordinary skill in the art at the time the invention was made to supply the bag of Marshall with the transparent cover, as taught by Keisic in order to provide the patient with the ability to easily view the quantity and quality of their urine as taught by Keisic in [0028].
Regarding claims 12-13, Marshall modified teaches the inventions substantially as claimed as set forth in the rejection of claim 1.
The difference between Marshall modified and claims 12-13 is the provision that the cutout has specific dimensions.
Keisic teaches the cutout in the form of a translucent window as shown in figure 1D.
It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the position and/or size of the translucent window within the cover as desired since it has been held that the mere change in size and/or shape of an element previously set forth in the prior art is considered to be within the level of ordinary skill in the art.
It is also noted that Marshall shows the urinary bag assembly wherein the cutout 57 may accommodate a junction of the inlet tube and the fluid bag as shown in figure 2.
Regarding claim 14, see the rejection of claim 1.
Keisic teaches a cutout that allows a determination of when the fluid bag is full without moving the cover from the obscuring orientation to a viewing orientation, since the cover is disclosed as being transparent as set forth in [0028] of Keisic.
Regarding claim 15, Marshall discloses urinary bag assembly, wherein the cover 50 (fig. 2) capable of being removed from the assembly.
Regarding claim 16, Marshall discloses urinary bag assembly, wherein said cover 50 is coupled to the fluid bag at or near an upper end of the fluid bag (see fig. 2).
Regarding claims 17 and 18, Marshall discloses urinary bag assembly, wherein the cover is coupled by hook and loop fasteners (col. 5, lines 33-34) that are operable to be detached, as required by claim 18.
Regarding claim 19, Marshall discloses urinary bag assembly, wherein said inlet tube W (col. 5, line 49; fig. 2) is coupled to the upper portion of the fluid bag with a valve assembly including an anti-reflux valve X (col. 5, line 47).
Regarding claim 20, Marshall discloses urinary bag assembly, wherein said outlet tube includes the outflow valve Z (col. 5, line 50; fig. 2) that is an output regulator.
Regarding claim 24, Marshall modified discloses the invention discussed above but do not expressly disclose the bag, wherein the cover extends beyond a bottom edge of the fluid bag.
Since Applicant did not state that such placement serves any specific purpose or performs any specific function other that the function disclosed in Marshall/ Salvadori, it would have been obvious top those skilled in the art at the time the invention was made to make the cover extending beyond a bottom edge of the fluid bag in order to convenience operation of the device as an obvious design choice, and as such it does not impact the patentability of claim 24.
Mere changes in size and/or shape of an element previously set forth in the prior art is considered to be within the level of ordinary skill in the art.
Claim 21 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Marshall (US 8,361,044) in view of Keisic (US 2011/0224636) and Salvadori et al. (US 2007/0203463) and further in view US 3,537,456.
Regarding claim 21, Marshall modified teaches the invention substantially as claimed as set forth in the rejection of claim 1.
The difference between Marshall modified and claim 21 is the provision that the s urinary bag assembly comprising an output opening that is a holder retaining the outlet tube in a upright position.
US 5,357,456 (hereinafter “Williams”) teaches an analogous container having an output opening that is a holder retaining the outlet tube in a upright position as shown in figure 1.
It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the output opening of Marshall modified to provide on that retains the outlet tube in an upright positions as taught by Williams in order to prevent accidental leakage as taught by Williams in col. 2, lines 53-66.
Claim 3 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Marshall (US 8,361,044) in view of Keisic (US 2011/0224636) and Salvadori et al. (US 2007/0203463) and further in view of Farmer et al. (US 6,613,036).
Regarding claim 3, Marshall modified discloses the invention discussed above but do not expressly disclose the bag, wherein said cover has a color that alters a urine color when viewed through said cover compared to the urine color when viewed without said cover.
In the same field of endeavor, i.e. fluid collection bag, Farmer teaches a fluid collection container (Abstract, line 1-4), wherein the transparent panel comprises a color (col. 7, lines 34-36) necessarily altering a color of the bag content viewed through said panel compared to the content color when viewed without said cover.
It would have been obvious to one having ordinary skill in the art at the time the invention was made to provide the cover of Marshall modified with the color that alters a urine color, as taught by Farmer in order to identify large particulates within the reservoir, as motivated by Farmer (col. 7, lines 30-31).
Claims 6-9 and 25 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Marshall (US 8,361,044) in view of Keisic (US 2011/0224636) and Salvadori et al. (US 2007/0203463) and further in view of Boone (US 4,874,387).
Regarding claims 6-9, Marshall modified discloses the invention discussed above but do not expressly disclose the bag, wherein said cover is operable to allow direct viewing of at least a portion of the front panel of the fluid bag upon lifting the cover.
In the same field of endeavor, collection bags, Boone teaches a cover for a body fluid drainage bag (Abstract, line 1) comprising a cover flap 36a (col. 2, line 68; fig. 1) covering the window 34 (fig. 1), and therefore, interpreted as being a cover, having a bottom edge that can be lifted from the bottom portion of the cover, as required by claim 8, allowing direct viewing of such that reveal the volume indicator 18 (fig. 1), as required by claims 6, 7 and 9.
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It would have been obvious to one having ordinary skill in the art at the time the invention was made to provide the bag of Marshall modified with the cover flap, as taught by Boone in order to allow the user to periodically check drainage into the drainage bag, as motivated by Boone (col. 4, line 15).
Regarding claim 25, Marshall modified discloses the invention discussed above but do not expressly disclose the cover lacking a window.
Boone teaches an analogous cover (18) lacking a window as shown in figure 1.
It would have been obvious to one having ordinary skill in the art at the time the invention was made to provide the bag of Marshall modified with the cover flap, as taught by Boone in order to allow the user to periodically check drainage into the drainage bag, as motivated by Boone (col. 4, line 15). The substitution of one type of cover for another is considered to be within the level of ordinary skill in the art.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-25 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 and 10-15 of U.S. Patent No. 11,497,842. Although the claims at issue are not identical, they are not patentably distinct from each other because:
All the limitations of claim 1 of the Application are to be found in claim 1 of the Patent.
The difference lies in the fact that the copending claims include more elements and are thus much more specific. Thus, the invention of the Patent claim 1 is in effect a "species" of the "generic" invention of the claim 1 of the Application. It has been held that the generic invention is "anticipated” by the “species". See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993). Since claim 1 of the Application is anticipated by claim 1 of the Patent, it is not patentably distinct from the claim 1 of the Patent.
All the limitations of claim 2 of the Application are to be found in claim 1 of the Patent.
All the limitations of claim 4 of the Application are to be found in claim 1 of the Patent.
All the limitations of claim 5 of the Application are to be found in claim 1 of the Patent.
All the limitations of claim 6 of the Application are to be found in claim 2 of the Patent.
All the limitations of claim 7 of the Application are to be found in claim 2 of the Patent.
All the limitations of claim 8 of the Application are to be found in claim 3 of the Patent.
All the limitations of claim 9 of the Application are to be found in claim 3 of the Patent.
All the limitations of claim 10 of the Application are to be found in claim 4 of the Patent.
All the limitations of claim 11 of the Application are to be found in claim 1 of the Patent.
All the limitations of claim 12 of the Application are to be found in claim 1 of the Patent.
All the limitations of claim 13 of the Application are to be found in claim 5 of the Patent.
All the limitations of claim 14 of the Application are to be found in claim 1 of the Patent.
All the limitations of claim 15 of the Application are to be found in claim 6 of the Patent.
All the limitations of claim 16 of the Application are to be found in claim 1 of the Patent.
All the limitations of claim 17 of the Application are to be found in claim 7 of the Patent.
All the limitations of claim 18 of the Application are to be found in claim 8 of the Patent.
All the limitations of claim 19 of the Application are to be found in claim 1 of the Patent.
All the limitations of claim 20 of the Application are to be found in claim 10 of the Patent.
All the limitations of claim 21 of the Application are to be found in claim 11 of the Patent.
All the limitations of claim 22 of the Application are to be found in claim 12 of the Patent.
All the limitations of claim 23 of the Application are to be found in claim 13 of the Patent.
All the limitations of claim 24 of the Application are to be found in claim 14 of the Patent.
All the limitations of claim 25 of the Application are to be found in claim 15 of the Patent.
Claim 3 depends on claim 1 and fall therewith.
Response to Arguments
Applicant’s arguments with respect to claims 1-25 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHELE M KIDWELL whose telephone number is (571)272-4935. The examiner can normally be reached Monday-Friday, 7AM-4PM EST.
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/MICHELE KIDWELL/Primary Examiner, Art Unit 3781
